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Objects clause and exclusion from patentability – are biotech related patents under attack in Australia?

The Australian Patent Office has released a consultation paper which seeks public comment on the proposed amendments to the Australian Patents Act 1990 (‘the Act’) to introduce an object clause and a patentability exclusion to prevent the commercialisation of inventions that would be “wholly offensive to the Australian public”.

While both proposed amendments are “technology neutral” in that they do not refer to a specific technology area, it is highly likely that the application of these amendments, particularly the patentability exclusion, will be found on applications and patents in the biotech space.

Patentability exclusion

The current proposal is to exclude from patentable subject matter inventions the commercial exploitation of which would be offensive to the Australian public.

Readers of this article and the consultation paper will no doubt be familiar with provisions in the legal framework of other jurisdictions, such as Europe, Japan and New Zealand, that exclude inventions from patentability based on morality grounds.

The current proposal is to replace the existing provisions that exclude from patentability inventions that are ‘contrary to law’ with the following exclusion:

… exclusion for an invention the commercial exploitation which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public.

The reasoning given in the paper for the proposed exclusion is the possible non-compliance with Australia’s obligations under the World Trade Organization Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) of the existing “contrary to law” exclusion and the inability of the existing provision to address circumstances where there is a lawful use of an invention but where the Australian public object to commercialisation of the invention.

Should the proposal be implement in its current form, only patent applicants during prosecution would be faced with this objection and it could not be used as a ground to oppose the grant of an already accepted application or to revoke a granted patent. The paper acknowledges the difficulty Australian patent examiners will be faced with in implementing these provisions and has called for comment on a proposal to allow the Commissioner of Patents to seek non-binding advice and to decide the most appropriate way to seek the advice.

Biotech in the crosshairs

Equivalent morality-based bars to patentability in other jurisdictions have found most frequent application in the biotech space. In Europe, objections to the patentability of inventions of which “would be contrary to ‘ordre public’ or morality” have been made to inventions including transgenic mice, herbicide resistant plants, nucleic acids encoding for a naturally occurring hormone and various stem cell based technologies. In New Zealand the equivalent “contrary to morality” provision is used to object to the patentability of methods of medical treatment.

Whether the proposed amendment to the Act will give rise to objections to inventions of similar technology is unclear, however it is unlikely given the Australian Patent Office’s practice of granting patents to transgenic mice, transgenic plants, isolated nucleic acids, certain stem cell based inventions and methods of medical treatment.

While there does not appear to be a clear mechanism for a third party to object to the patentability of an invention should the Act be amended as proposed, potentially these provisions do provide special interests groups opposed to the patenting of an invention on ethical grounds some way to influence the examination process. Will the Australian Patent Office only raise objections based on the proposed patentability exclusion of their own volition, or will they be influenced by third party correspondence? This is unclear at this stage.

It is worth noting that the specific exclusion is for an invention “the commercial exploitation” of which would be wholly offensive. What this suggests is that invention the creation of which would be wholly offensive should not per se be excluded. For example, consider a hypothetical situation where the Australian public considers use of transgenic mice as wholly offensive. A transgenic mouse model of human cancer is used to identify a small molecule that inhibits cancer metastasis and a patent to this compound is applied for. The proposed provision should not be a bar to the patentability of this compound as the commercial exploitation would involve chemically synthesis of the compound and beneficial medical treatment without any further involvement of the transgenic mouse.

Object clause

In response to a number of reviews into the types of subject matter that should be patentable in Australia, the Australian Government accepted a recommendation to introduce an object clause into the Act. Amending an Act so long after its initial commencement to include a statement as to its purpose might seem odd but the introduction of an object clause, along with the patentability exclusion, appears to be a political compromise between those for and against a legislative change to the test for what is patentable subject matter.

In legislative interpretation an object clause can serve to outline the underlying purposes of the legislation or to set out overall aims and principles that can assist to interpret the provisions of the legislation.

The specific purpose of including an objects clause in the Act is to clarify the interaction between the patents system and competition policy.

Two potential objects clauses are provided in the consultation paper including the following:

…the purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.

It is unclear how the object clause stated above, or the alternative clause given in the paper, would be used by Australian courts to interpret provisions of the Act. However, it is unlikely that clear statutory language could be varied by such a clause.